Atopic DermatitisPhase 4NCT00654355
Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
A Phase 4 study testing tacrolimus ointment in people with Atopic Dermatitis, run by Wake Forest University at 1 site in United States.
Trial summary
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- tacrolimus ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects age 2-15.
- Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.
Who cannot join
- Known allergy to tacrolimus or to any component of the formulations.
- The use of systemic therapy for atopic dermatitis within the past 4 weeks.
- Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
- Use of any investigational therapy within the past 4 weeks.
- Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week 4.
- Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dept of Dermatology, WFUHS
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
Read the detailed description
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.
- Conditions
- Atopic Dermatitis
- Being tested
- tacrolimus ointment
- Keywords
- atopic dermatitis, eczema
- Medical subject headings
- Dermatitis, Atopic, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus ointmentDrug
Also called Protopic Ointment
tacrolimus ointment to be applied twice daily to affected areas during duration of study
| Study group | Role | What they receive |
|---|---|---|
| Active Drug | Experimental | tacrolimus ointment Receives: Drug: tacrolimus ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed
Measured: Week 4
Secondary outcomes (2)
The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.
Investigator Global Assessment: Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from '0' = clear or "No inflammatory signs of AD" to '4' = Very Severe Disease with "severe erythema and severe papulation/infiltration with oozing/crusting."
Measured: Week 4
EASI
Eczema Area and Severity Index (EASI): Disease severity will be assessed by a physician with the Eczema Area and Severity Index (EASI). This measure is commonly used and well validated instrument of eczema severity. It is weighted for area in each of the four body regions (which differs for adults and children under 7) and scores erythema, excoriation, induration/papulation, and lichenification. The total scores range from 0-72. Higher scores represent more severe eczema.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve Feldman, MD, PHD, Principal investigator, WFUHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654355
- Sponsor's protocol ID
- IRB00002300
- Other IDs
- contract #32417
- Status last verified
- Jul 2018
- First submitted
- 2 Apr 2008
- Last updated
- 1 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Adherence to Topical Therapy in Children With Atopic Dermatitis and the Impact of a Return Visit
- ClinicalTrials.gov ID
- NCT00654355
- Acronym / sponsor ID
- IRB00002300
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Apr 2008 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to better understand how the study drug works when people use it to treat atopic dermatitis.
Detailed description
To evaluate adherence to topical therapy using adherence data collected by the MEMS cap (Medication Electronic Monitoring System) in pediatric patients with atopic dermatitis (AD) and the impact of a return visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Drug | Experimental | Drug: tacrolimus ointmenttacrolimus ointment |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Male or female subjects age 2-15.
- Stable or worsening atopic dermatitis affecting 5% or greater body surface area. Face and genital areas can be included in the body surface area determination and treatment area.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
- The ability to understand and sign a written informed consent/assent form, which must be obtained prior to treatment.
Key exclusion criteria (6 listed)
- Known allergy to tacrolimus or to any component of the formulations.
- The use of systemic therapy for atopic dermatitis within the past 4 weeks.
- Use of prescription topical therapy for atopic dermatitis (e.g., corticosteroids or retinoids) within the past 2 weeks.
- Use of any investigational therapy within the past 4 weeks.
- Pregnant females, females who are breast feeding, or females of childbearing potential who are not practicing an acceptable method of birth control (abstinence, birth control pill/patch, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. Acceptable contraception must be used during the entire study. A pregnancy test will be performed on females of childbearing potential at baseline and at week 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tacrolimus ointmentAlso: Protopic Ointmenttacrolimus ointment to be applied twice daily to affected areas during duration of study | Drug | Active Drug |
Primary outcome
Adherence
Time frame: Week 4
adherence to topical therapy in children via MEMS cap in a "real-life" clinic population measured as the % of required applications completed
2 secondary outcomes
The % Change From Baseline to Week 4 (or End of Treatment) in the IGA.
Time frame: Week 4
EASI
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Feldman, MD, PHD principal investigator
WFUHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tacrolimus ointment in people with Atopic Dermatitis, run by Wake Forest University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.